Scholar Rock announced On Track to Initiate Phase 2 Proof-of-Concept Study in Later-Onset SMA in 1Q19

Scholar Rock made transformative progress in the second quarter with the successful completion of our IPO and the initiation of the Company’s first clinical trial,” said Nagesh Mahanthappa, Ph.D, President and CEO of Scholar Rock. “We are well-positioned to continue to progress SRK-015 and build our pipeline of future product… Att fortsätt läsa

Scholar Rock Announces Completion of Dosing of First Cohort in Phase 1 Clinical Trial of SRK-015 for SMA

The placebo-controlled, double-blind Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of intravenous SRK-015 in healthy adult volunteers. Assuming the successful completion of the Phase 1 trial, the Company plans to initiate a Phase 2 proof-of-concept trial in the first quarter… Att fortsätt läsa

Scholar Rock erhielt von der FDA den Orphan-Arznei-Status für SRK-015 zur Behandlung von Patienten mit spinaler Muskelatrophie

CAMBRIDGE, Massachusetts, 29. März 2018 – Scholar Rock, ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung von Medikamenten zur Behandlung schwerer Erkrankungen konzentriert, bei denen die Signalübertragung durch Proteinwachstumsfaktoren eine fundamentale Rolle spielt, gab heute bekannt, dass die US-amerikanische Gesundheitsbehörde FDA (Food and Drug Administration) hat seinem Hauptantikörperproduktkandidaten SRK-015 die… Att fortsätt läsa

Scholar Rock Granted Orphan Drug Designation by the FDA for SRK-015

for the Treatment of Patients with Spinal Muscular Atrophy CAMBRIDGE, Mass., March 29, 2018 – Scholar Rock, a biopharmaceutical company focused on developing medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role, today announced that the U.S. Food and Drug Administration… Att fortsätt läsa